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Nail PsoriasisPhase 4NCT06578728

Local Methotrexate Injections for the Treatment of Nail Psoriasis

A Phase 4 study testing Methotrexate, Triamcinolone Acetonide 10mg/mL and Saline in people with Nail Psoriasis, run by Weill Medical College of Cornell University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The investigators hope to learn the efficacy of methotrexate injections for treatment of nail psoriasis. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Nail Psoriasis
What is being tested?
Methotrexate, Triamcinolone Acetonide 10mg/mL and Saline
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1 participants
Where
1 siteUnited States
Study dates
10 Sep 2025to 5 Jun 2026
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject must be at least 18 years of age
  • Subject must have nail psoriasis that is clinically diagnosed in at least 3 fingernails

Who cannot join

  • Subject with any clinically significant condition or situation, other than the condition being studied that, in the opinion of the investigator, would interfere with study evaluations or optimal participation in the study. This is including, but not limited to: immunodeficiency, onychomycosis, any other nail condition other than psoriasis, allergy to methotrexate, triamcinolone acetonide, local anesthetic, normal saline, or any other material used for procedures
  • Subject who has received radiation therapy, chemotherapy, and/or immunosuppressive drugs within 6 months of study, and/or oral corticosteroids or IV methotrexate for >1 month within the 6 months of study (exception inhaled steroids);
  • Subjects who use substances (medications, supplements, ect) known to significantly interact with drugs used as intervention in the study
  • Subject who is pregnant, breastfeeding, or planning to get pregnant
  • Subject known to have received treatment with investigational drugs or devices within 30 days prior to enrollment into this study
  • Subject who is on systemic treatment for psoriasis
Show all 11Show fewer
  • Subject with baseline abnormalities in liver function tests or complete blood count
  • Subjects with diagnosis of renal insufficiency or impairment
  • Subject who is unwilling to abstain from any cosmetic nail treatments outside those provided by the study clinic, beyond basic nail trimming (i.e. no spa nail treatments, no nail polish use, no other topical prescription nail medication)
  • Subject who is unwilling to abstain from any medical nail treatments on their nails other than the study intervention (i.e. topical steroids, antifungal creams) for the duration of the study intervention and for duration of the washout period (if applicable)
  • Subject who is part of the staff personnel directly involved with this study or a family member of the investigational study staff

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Israel Englander Department of Dermatology

    New York, New York, 10021

Other trials in United States

About this study

Official title: Intralesional Methotrexate Injections for the Treatment of Nail Psoriasis: an Intra-subject Randomized Controlled Trial

The investigators hope to learn the efficacy of methotrexate injections for treatment of nail psoriasis.

Conditions
Nail Psoriasis
Being tested
Methotrexate, Triamcinolone Acetonide 10mg/mL, Saline
Keywords
methotrexate, triamcinolone acetonide

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MethotrexateDrug

    25mg/mL intralesional injection into nail bed/nail matrix

  • Triamcinolone Acetonide 10mg/mLDrug

    10mg/mL intralesional injection into nail bed/nail matrix

  • SalineDrug

    saline intralesional injection into nail bed/nail matrix

Study groups in NCT06578728
Study groupRoleWhat they receive
Intralesional MethotrexateExperimentalParticipants receive intralesional methotrexate injections into 1 nail bed/nail matrix every 6 weeks for 3 sessions.
Receives: Drug: Methotrexate
Intralesional Triamcinolone AcetonideActive comparatorParticipants receive intralesional triamcinolone acetonide injections into 1 nail bed/nail matrix every 6 weeks for 3 sessions.
Receives: Drug: Triamcinolone Acetonide 10mg/mL
Intralesional Placebo (saline)Placebo comparatorParticipants receive intralesional saline injections into 1 nail bed/nail matrix every 6 weeks for 3 sessions.
Receives: Drug: Saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline of nail dystrophy as measured by the Nail Psoriasis Severity Index

    Mean change from baseline of the Nail Psoriasis Severity Index, which evaluates nail psoriasis symptoms with a score of 0-8 for each nail. Scores will be collected and analyzed per nail. For each nail measured by the study, patients can have a score between 0 and 8.

    A score of 0 indicates no symptoms of nail psoriasis in the nail, and a score of 8 indicates nail psoriasis features are present in four quadrants of both the nail bed and nail matrix.

    Measured: Baseline (week 0), during intervention (weeks 1, 7, 13), post-intervention (weeks 17, 37)

  2. Change from baseline of nail dystrophy as measured by the Physician-Assessed Global Improvement

    Mean change from baseline in physician-assessed global improvement severity rating which rates each nail on a 5-point scale (rating 0 - 4) based on the presence of nail plate pitting, crumbling, onycholysis, oil-drop discoloration, or nail bed hyperkeratosis.

    A score of 0 indicates none of the listed symptoms, while a score of 4 indicates severe symptoms. Scores will be collected and analyzed per nail.

    Measured: Baseline (week 0), during intervention (weeks 1, 7, 13), post-intervention (weeks 17, 37)

Secondary outcomes (1)

  1. Treatment-Related Adverse Events

    Number of participants with either treatment-related adverse events or treatment-related side effects in each treatment arm.

    Measured: 37 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Aug 2024
  2. Study start10 Sep 2025
  3. Primary completion5 Jun 2026
  4. Study completion5 Jun 2026

Why it stopped: The study was terminated due to slow accrual.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Intra-subject randomized controlled trial
Masking
Single blind
Who is masked
Participant
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06578728
Sponsor's protocol ID
23-09026516
Status last verified
Jun 2026
First submitted
27 Aug 2024
Last updated
17 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Crowley JJ, Weinberg JM, Wu JJ, Robertson AD, Van Voorhees AS; National Psoriasis Foundation. Treatment of nail psoriasis: best practice recommendations from the Medical Board of the National Psoriasis Foundation. JAMA Dermatol. 2015 Jan;151(1):87-94. doi: 10.1001/jamadermatol.2014.2983.

    PubMed 25471223

  • de Berker D. Management of nail psoriasis. Clin Exp Dermatol. 2000 Jul;25(5):357-62. doi: 10.1046/j.1365-2230.2000.00663.x.

    PubMed 11012585

  • Baran R. [How to diagnose and treat psoriasis of the nails]. Presse Med. 2014 Nov;43(11):1251-9. doi: 10.1016/j.lpm.2014.06.011. Epub 2014 Oct 16. French.

    PubMed 25443636

  • Edwards F, de Berker D. Nail psoriasis: clinical presentation and best practice recommendations. Drugs. 2009;69(17):2351-61. doi: 10.2165/11318180-000000000-00000.

    PubMed 19911853

  • de Jong EM, Seegers BA, Gulinck MK, Boezeman JB, van de Kerkhof PC. Psoriasis of the nails associated with disability in a large number of patients: results of a recent interview with 1,728 patients. Dermatology. 1996;193(4):300-3. doi: 10.1159/000246274.

    PubMed 8993953

  • Armstrong AW, Tuong W, Love TJ, Carneiro S, Grynszpan R, Lee SS, Kavanaugh A. Treatments for nail psoriasis: a systematic review by the GRAPPA Nail Psoriasis Work Group. J Rheumatol. 2014 Nov;41(11):2306-14. doi: 10.3899/jrheum.140881.

    PubMed 25362716

  • Kivelevitch D, Frieder J, Watson I, Paek SY, Menter MA. Pharmacotherapeutic approaches for treating psoriasis in difficult-to-treat areas. Expert Opin Pharmacother. 2018 Apr;19(6):561-575. doi: 10.1080/14656566.2018.1448788. Epub 2018 Mar 22.

    PubMed 29565192

  • Rigopoulos D, Baran R, Chiheb S, Daniel CR 3rd, Di Chiacchio N, Gregoriou S, Grover C, Haneke E, Iorizzo M, Pasch M, Piraccini BM, Rich P, Richert B, Rompoti N, Rubin AI, Singal A, Starace M, Tosti A, Triantafyllopoulou I, Zaiac M. Recommendations for the definition, evaluation, and treatment of nail psoriasis in adult patients with no or mild skin psoriasis: A dermatologist and nail expert group consensus. J Am Acad Dermatol. 2019 Jul;81(1):228-240. doi: 10.1016/j.jaad.2019.01.072. Epub 2019 Feb 5.

    PubMed 30731172

  • Grover C, Daulatabad D, Singal A. Role of nail bed methotrexate injections in isolated nail psoriasis: conventional drug via an unconventional route. Clin Exp Dermatol. 2017 Jun;42(4):420-423. doi: 10.1111/ced.13087. Epub 2017 Apr 10.

    PubMed 28397295

  • Jiaravuthisan MM, Sasseville D, Vender RB, Murphy F, Muhn CY. Psoriasis of the nail: anatomy, pathology, clinical presentation, and a review of the literature on therapy. J Am Acad Dermatol. 2007 Jul;57(1):1-27. doi: 10.1016/j.jaad.2005.07.073.

    PubMed 17572277

  • Wolf R, Tur E, Brenner S. Corticosteroid-induced 'disappearing digit'. J Am Acad Dermatol. 1990 Oct;23(4 Pt 1):755-6. doi: 10.1016/s0190-9622(08)81079-1. No abstract available.

    PubMed 2229508

  • Requena L, Zamora E, Martin L. Acroatrophy secondary to long-standing applications of topical steroids. Arch Dermatol. 1990 Aug;126(8):1013-4. No abstract available.

    PubMed 2383026

  • Deffer TA, Goette DK. Distal phalangeal atrophy secondary to topical steroid therapy. Arch Dermatol. 1987 May;123(5):571-2. No abstract available.

    PubMed 3579338

  • Tosti A, Piraccini BM, Cameli N, Kokely F, Plozzer C, Cannata GE, Benelli C. Calcipotriol ointment in nail psoriasis: a controlled double-blind comparison with betamethasone dipropionate and salicylic acid. Br J Dermatol. 1998 Oct;139(4):655-9. doi: 10.1046/j.1365-2133.1998.02462.x.

    PubMed 9892909

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Methotrexate, Triamcinolone Acetonide 10mg/mL and Saline in people with Nail Psoriasis, run by Weill Medical College of Cornell University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: The study was terminated due to slow accrual.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline of nail dystrophy as measured by the Nail Psoriasis Severity Index (time frame: Baseline (week 0), during intervention (weeks 1, 7, 13), post-intervention (weeks 17, 37)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06578728, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.

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